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FDA Authorizes Quanterix's Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test For Emergency Use

The U.S. Food and Drug Administration has authorized the emergency use of Quanterix Corp.'s (QTRX) Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test. The test could be run on the Simoa HD-X Analyzer, a fully automated high-throughput immunoassay instrument.

The Simoa Semi-Quantitative SARS-CoV-2 antibody test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein. The spike protein contains multiple subunits which together mediate entry of the virus into human cells, and for this reason candidate and authorized COVID-19 vaccines are designed to elicit an antibody response to spike protein.

The company stated that the Simoa Semi-Quantitative SARS-CoV-2 may therefore be useful for measuring the antibody response to vaccine therapy. The assay may also be used for measurement of IgG antibodies in patients suspected of previous infection or recent SARS-CoV-2 exposure.

The test provides a numerical result representing the concentration of antibodies from 0.21 to 250 µg/mL.

The company said that, in clinical studies, the test demonstrated a 100 percent positive percent agreement (sensitivity) and 99.2 percent negative percent agreement (specificity) 15 or more days following a positive PCR test.

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